Trevena Announces Positive Results from Post-Approval Study of OLINVYK

Trevena

CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN) recently reported positive topline results from its post-approval study designed to assess the impact on cognitive function in subjects treated with OLINVYK compared to IV morphine. The Company also provided a general business update including recent realignment of resources and cost reductions, as well as progress on the US commercial launch of OLINVYK and the Company’s pipeline assets.

“We are pleased to announce the positive topline cognitive function data and a major contract win for OLINVYK,” said Carrie Bourdow, President and CEO of Trevena. “We also remain focused on advancing the clinical studies for TRV045, our novel S1P receptor modulator, and our recent corporate realignment will help us increase financial flexibility to drive forward our strategic priorities.”

Cognitive Function Study
OLINVYK was studied in a randomized, double-blind, placebo-controlled, dose-ranging design, in collaboration with the Netherlands-based Center for Human Drug Research. Subjects received single intravenous doses of OLINVYK 1 mg and 3 mg, or morphine 5 mg and 10 mg, or placebo, using a partial-block crossover design. A comprehensive battery of neurocognitive and motor assessments was obtained following each blinded dose, which included measures of Sedation/Reaction Time, Visual Tracking, Higher-order Cognitive Processing, Motor Function and Eye-Hand Coordination. Twenty-three healthy subjects participated in the study, including 13 males and 10 females, with a median age of 26.

Overall, OLINVYK showed evidence of a reduced impact on neurocognitive function compared to IV morphine.

Key Findings:

  • Primary Endpoint. OLINVYK showed a statistically significant reduction in sedation versus IV morphine, measured by saccadic eye movement peak velocity, a sensitive laboratory measure of sedating action of medications. The prespecified mixed-model repeated measures ANOVA highlighted a difference between treatments (main effect of treatment, P<0.0001), driven by a reduced impact of OLINVYK versus IV morphine (P=0.0236).
  • Secondary Endpoints. On several of the prespecified secondary outcome measures, OLINVYK showed a statistically significant difference or trend compared to IV morphine, despite the relatively small sample size, across a range of neurocognitive measures and motor performance:
    • Reaction Time. Reduced impact on saccadic eye movement reaction time (main effect, P=0.0201) (OLINVYK vs IV morphine, P=0.0273)
    • Postural Stability (Motor Function). Reduced body sway, a measure of motor function (main effect, P=0.0314) (OLINVYK vs IV morphine, P=0.0951)
    • Eye-Hand Coordination. Reduced performance accuracy on the adaptive tracking test, a measure of eye-hand coordination (main effect, P=0.0011), (OLINVYK vs IV morphine, P=0.1303)
    • Target Engagement (Pupillometry and Analgesia). Across the dose ranges studied, both OLINVYK and IV morphine demonstrated expected effects on opioid-induced pupillary constriction, and analgesia in response to cold pain testing
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Other secondary outcome measures, including visual tracking and higher-order cognitive processing did not show statistical differences between OLINVYK and IV morphine. No serious adverse events were observed in the study, and adverse events were generally assessed as mild.

“Neurocognitive function including sedation and postural instability may have important consequences in the clinical care setting with the use of opioid medications.” said Mark Demitrack, M.D. Chief Medical Officer of Trevena. “Mitigating the impact of these adverse events may have important implications for length of stay and other health economic outcomes.”

Trevena General Business Updates

  • Executed a contract in July with a leading hospital group purchasing organization (GPO), which will allow for broad OLINVYK access for member hospitals. The hospital GPO has coverage across US academic medical centers, acute care hospitals and ambulatory surgical centers.
  • Implemented a realignment of Company resources in July to maintain focus on key value drivers and extend cash runway to mid-2023. The Company implemented a ~25% reduction in full-time employees and terminated its contract sales force agreement with Syneos. Trevena maintains a focused internal commercial and medical affairs team supporting OLINVYK. The Company effected other general expense reductions that the Company believes will collectively help reduce operating expenses and extend the cash runway to mid-2023. The Company believes these decisions allow Trevena to continue to sufficiently resource its key strategic priorities of driving commercial adoption of OLINVYK and developing TRV045.
  • Continued to advance Phase 1 study of TRV045, our novel S1P receptor modulator, for diabetic neuropathic pain; on track for completion 2H 22. TRV045 is a novel, selective sphingosine-1 phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a preclinical collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy, with possible application in refractory epilepsy and other rare or orphan seizure disorders.
  • Maintained approximately $49.5 million in cash and equivalents at June 30, 2022, which the Company believes will be sufficient to fund the Company’s operating expenses and capital expenditure requirements to mid-2023. There were no net sales of OLINVYK for the quarter ended June 30, 2022. The cash balance includes net proceeds in April from the first $15 million tranche of the royalty-based financing agreement with an affiliate of R Bridge Healthcare Fund.
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See Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

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